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Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT00821353
First received: January 11, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.

Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.

Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.


Condition Intervention Phase
Atrial Fibrillation
Hypertrophic Cardiomyopathy
 Procedure: RF catheter ablation
Drug: Antiarrhythmic drugs
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in total symptomatic and asymptomatic AF burden. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence of complications. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Changes in left atrial diameter and left ventricular function. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in level of Nt-pro-BNP. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in symptom severity and quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in exercise capacity assessed by cardiopulmonary exercise testing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RFCA Procedure: RF catheter ablation
RF catheter ablation
Active Comparator: Drug Drug: Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

Exclusion Criteria:

  • Severe hear failure (NYHA IV)
  • Left ventricular ejection fraction <0.30
  • Left atrial diameter >65 mm
  • Age > 70 years
  • Contraindication to anticoagulation with warfarin
  • Presence of a mechanical prosthetic valve
  • Presence of left atrial thrombus on TEE or CT
  • Woman currently pregnant
  • Renal failure (GFR < 30 ml/min)
  • Hepatic failure
  • Untreated hypothyroidism or hyperthyroidism
  • LVOT gradient > 50 mmHg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821353

Locations
Poland
Institute of Cardiology
Warsaw, Poland
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Principal Investigator: Pawel Derejko, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Lidia Chojnowska, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Lukasz Szumowski, MD, PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Franciszek Walczak, MD, PhD Institute of Cardiology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Pawel Derejko M.D. Ph.D., Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT00821353     History of Changes
Other Study ID Numbers: N N402 194635, 1.7/IV/08
Study First Received: January 11, 2009
Last Updated: February 4, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Atrial fibrillation
Hypertrophic cardiomyopathy
RF ablation
Antiarrhythmic drugs

Additional relevant MeSH terms:
Atrial Fibrillation
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013